Next Generation ORS: Randomized Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity With Acute Watery Diarrhea in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Stool Volume Output
研究概览
简要总结
Diarrhea remains a leading killer of children in need of better treatments.
详细描述
Diarrhea remains a leading killer of children in need of better treatments. Oral Rehydration Solution (ORS) is currently the only oral therapy that is recommended for children with acute diarrhea. Although it is valuable for correcting dehydration and is considered the primary reason for the substantial reduction in mortality from diarrhea in children, ORS does not have the capacity to "halt" intestinal fluid loss and thus, does not offer a rapid relief of a child's diarrhea symptom, and its use by caregivers and medical practitioners has markedly dropped (estimate use in 1/3 of cases who need it). In recognition of its limitations, continuous efforts have been made to modify the composition of ORS. However, none has targeted the central diarrhea-causing pathways and produced a satisfactory outcome in children. New therapeutic approaches and methods are needed. The proposed new ORS is based on recent discovery of the first inclusive antidiarrheal mechanism in the intestine, CaSR (calcium-sensing receptor) that targets all known diarrhea causing pathways. It works in animals. This R21 is the 1st proof-of-concept clinical study in humans and is intended to investigate its safety and efficacy. Two Specific Aims are proposed to determine new ORS safety and efficacy in patients with diarrhea. In the safety study, the investigators propose to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS). In the efficacy study, the investigators plan to enroll 396 diarrheal adults (198 in Intervention New ORS group and 198 in standard WHO ORS, these will be same patients employed for the safety study). These diarrheal patients will be recruited from the Dhaka area in Bangladesh. At the conclusion of the study, we expect to develop a novel oral rehydrating solution that is inexpensive and practical to use in all the countries. Hypothesis: the volume output Intervention should reduce stool weight/output of diarrhea by 30%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients, age between 18 and 60 years, history of acute watery diarrhea (defined as the passage of ≥3 loose or watery stools in the past 24 hours) for less than 24 h before admission, either signs of severe dehydration and stool positive for Vibrio cholerae, and successful rehydration with intravenous fluids within the first 6 h after admission (cholera group), or signs of some dehydration and stool negative for V. cholera (non-cholera group) , and successful rehydration with intravenous or oral fluids within the first 6 h
排除标准
- •Pregnancy as determined by history of last menstrual period, bloody diarrhea, signs of systemic infection that needed intravenous antibiotics, or inability to rehydrate with intravenous fluid therapy in the first 6 h after admission.
研究组 & 干预措施
Nutrient based intervention
Nutrition supplement used to stop diarrhea
干预措施: Next Generation ORS (oral rehydration solution) (including placebo (Drug)
Standard of Care oral rehydration solution
Standard of care nutrition supplement used to stop diarrhea.
干预措施: Current standard control ORS (oral rehydration solution) (Drug)
结局指标
主要结局
Stool Volume Output
时间窗: Year 2
Stool output is defined as the weight of stool in g per kg bodyweight after initial intravenous and or oral hydration
Stool Output
时间窗: Day 1, day 2, Day 3, and entire 3 days
Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.
次要结局
- Stool frequency(year 2)
- Percentage of patients who require unscheduled intravenous therapy(year 2)
- Intake of ORS(year 2)
- Duration of diarrhea(year 2)
- Percentage of patients who vomit(year 2)
- Duration of Diarrhea(from randomization to end of treatment at day 3)
- Stool Frequency(Day 1, Day 2, Day 3)
- Vomiting(Day 1, Day 2, Day 3)
- Percentage of Patients Who Require Unscheduled Intravenous Therapy(Day 1, Day 2, Day 3)
- Intake of ORS(Day 1, Day 2, Day 3)